HYMPAVZI Highlights

(marstacimab-hncq)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYMPAVZI safely and effectively. See full prescribing information for HYMPAVZI.

HYMPAVZI (marstacimab-hncq) injection, for subcutaneous use
Initial U.S. Approval: 2024

INDICATIONS AND USAGE

HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:

•
hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
•
hemophilia B (congenital factor IX deficiency) without factor IX inhibitors. (1)

DOSAGE AND ADMINISTRATION

•
See Full Prescribing Information for important dosing and administration instructions. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)
•
The recommended dosage of HYMPAVZI is:
o
Loading dose: 300 mg (two 150 mg injections) by subcutaneous injection
o
Maintenance dose: One week after the loading dose, initiate maintenance dosing of 150 mg every week by subcutaneous injection on the same day each week, at any time of day. (2.1)
•
Dose adjustment to 300 mg subcutaneous injection weekly can be considered. (2.1)
•
Factor VIII and factor IX products can be administered for the treatment of breakthrough bleeds in patients receiving HYMPAVZI. Do not use additional doses of HYMPAVZI to treat breakthrough bleeds. (2.4)
•
Temporarily discontinue HYMPAVZI before major surgery. (2.5)

DOSAGE FORMS AND STRENGTHS

•
Injection: 150 mg/mL in a single-dose prefilled syringe (3)
•
Injection: 150 mg/mL in a single-dose prefilled pen (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Thromboembolic Events: Thromboembolic events may occur. Interrupt HYMPAVZI prophylaxis if symptoms occur. (5.1)
•
Hypersensitivity: Hypersensitivity reactions may occur. In the event of a severe allergic reaction, discontinue HYMPAVZI. (5.2)
•
Embryofetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.3, 8.1, 8.3)

ADVERSE REACTIONS

Adverse reactions reported in ≥3% of HYMPAVZI-treated patients were injection site reaction, headache, and pruritus. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2024

Find HYMPAVZI medical information:

Find HYMPAVZI medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

HYMPAVZI Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYMPAVZI safely and effectively. See full prescribing information for HYMPAVZI.

HYMPAVZI (marstacimab-hncq) injection, for subcutaneous use
Initial U.S. Approval: 2024

INDICATIONS AND USAGE

HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:

•
hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
•
hemophilia B (congenital factor IX deficiency) without factor IX inhibitors. (1)

DOSAGE AND ADMINISTRATION

•
See Full Prescribing Information for important dosing and administration instructions. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)
•
The recommended dosage of HYMPAVZI is:
o
Loading dose: 300 mg (two 150 mg injections) by subcutaneous injection
o
Maintenance dose: One week after the loading dose, initiate maintenance dosing of 150 mg every week by subcutaneous injection on the same day each week, at any time of day. (2.1)
•
Dose adjustment to 300 mg subcutaneous injection weekly can be considered. (2.1)
•
Factor VIII and factor IX products can be administered for the treatment of breakthrough bleeds in patients receiving HYMPAVZI. Do not use additional doses of HYMPAVZI to treat breakthrough bleeds. (2.4)
•
Temporarily discontinue HYMPAVZI before major surgery. (2.5)

DOSAGE FORMS AND STRENGTHS

•
Injection: 150 mg/mL in a single-dose prefilled syringe (3)
•
Injection: 150 mg/mL in a single-dose prefilled pen (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Thromboembolic Events: Thromboembolic events may occur. Interrupt HYMPAVZI prophylaxis if symptoms occur. (5.1)
•
Hypersensitivity: Hypersensitivity reactions may occur. In the event of a severe allergic reaction, discontinue HYMPAVZI. (5.2)
•
Embryofetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.3, 8.1, 8.3)

ADVERSE REACTIONS

Adverse reactions reported in ≥3% of HYMPAVZI-treated patients were injection site reaction, headache, and pruritus. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2024
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.